STUDY OF PARALLEL, MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED DESIGN ON SAFETY AND EFFICACY OF THE COMBINATION OF TAK 559 AND GLIBENCLAMID COMPARED WITH PLACEBO AND GLIBENCLAMIDE IN THE TREATMENT OF PATIENTS WITH DIABETES MELLITUS TYPE 2

TAKEDA PHARMACEUTICALS,0 个研究点目标入组 0 人开始时间: 2004年5月28日最近更新: 2023年9月4日

试验速览

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•Must be diagnosed with type 2 diabetes mellitus using American Diabetes Association diagnostic criteria, and on a stable dose of an oral anti-diabetic monotherapy prior to Screening A.
•Has a glycosylated hemoglobin level greater than or equal to 8.0% and less than or equal to 10.0% at Screening B.
•Has a fasting plasma glucose greater than or equal to 126 mg/dL (7.0 mmol/L) at Screening B.
•Is taking a stable dose of at least 10 mg of glyburide for at least 10 days prior to Screening B.
•Has a stable or worsening self-monitoring blood glucose level while taking glyburide.
•The patient must have a low-density lipoprotein less than 160 mg/dL (4.1 mmol/L) at Screening A.
•Has a body mass index less than or equal to 45 kg/m2 at Screening A.

•Has been diagnosed with type 1 diabetes mellitus, hemochromatosis, or has a history of ketoacidosis.
•Has any condition known to invalidate glycosylated hemoglobin results (eg, hemolytic states, hemoglobinopathies).
•Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication

发起方

TAKEDA PHARMACEUTICALS,